The following data is part of a premarket notification filed by Vieworks Co., Ltd. with the FDA for Qxlink.
Device ID | K132302 |
510k Number | K132302 |
Device Name: | QXLINK |
Classification | System, Image Processing, Radiological |
Applicant | VIEWORKS CO., LTD. 1515 E. KATELLA AVENUE UNIT 2115 Anaheim, CA 92805 |
Contact | Priscilla Chung |
Correspondent | Priscilla Chung VIEWORKS CO., LTD. 1515 E. KATELLA AVENUE UNIT 2115 Anaheim, CA 92805 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-24 |
Decision Date | 2013-09-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QXLINK 79262941 not registered Live/Pending |
Vieworks Co., Ltd. 2019-05-21 |